Azelamed, 0.5 mg/ml, eye drops, solution, 1 bottle 6 ml

Azelamed contains azelastine, which belongs to the group of medicines called antihistamines. Antihistamines work by preventing the effects of histamine, which is produced by the body as a result of an allergic reaction. Azelastine has been shown to reduce eye inflammation.

Azelamed can be used to treat or prevent the symptoms of seasonal allergic eye disorders that accompany hay fever (seasonal allergic conjunctivitis) in adults, adolescents and children aged 4 years and over.

Azelamed can be used for eye disorders caused by allergy to substances such as house dust mites or animal hair (perennial conjunctivitis) in adults and adolescents aged 12 years and over.

Azelamed is not intended for the treatment of eye infections. If after 2 days you do not feel better or if you feel worse, contact your doctor.

The active substance is azelastine hydrochloride. 1 ml of solution contains 0.5 mg of azelastine hydrochloride. Each drop contains 0.015 mg of azelastine hydrochloride.

The other ingredients are: benzalkonium chloride, disodium edetate, hypromellose 4000, liquid, crystallising sorbitol, sodium hydroxide to adjust pH and water for injections.

Always use this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Do not use this medicine if the tamper evident seal on the bottle neck has been broken before first use. To open the bottle, unscrew the cap by turning it until the seal breaks.

Eye disorders caused by hay fever (seasonal allergic conjunctivitis)

• For adults, adolescents and children aged 4 years and over.
• The recommended dose is 1 drop in each eye, morning and evening.

If exposure to an allergen is anticipated, the recommended dose should be applied prophylactically before leaving the house.

Eye disorders caused by allergy (non-seasonal (perennial) conjunctivitis)

• For adults, adolescents and children aged 12 years and over.
• The recommended dose is 1 drop in each eye, morning and evening.

For severe symptoms, your doctor may increase the dose to 1 drop in each eye, four times daily.
Relief of allergic conjunctivitis symptoms should occur within 15-30 minutes.

If possible, use Azelamed regularly until your symptoms disappear. If you stop using Azelamed, your symptoms may return.

Please remember:

• not to use Azelamed for longer than 6 weeks,
• to apply Azelamed only to the eyes.

How to administer Azelamed
To apply the eye drops correctly, you can sit in front of a mirror during the first few instillations.

1. Wash your hands.
2. Using a clean disposable tissue, gently dry the eye area.
3. Unscrew the cap and check that the dropper is clean.
4. Gently pull the lower eyelid down.
5. Carefully place the drop inside the lower eyelid. Be careful not to touch the eye with the dropper.
6. Then release the eyelid and then gently press the inner corner of the eye on the side of the nose. While pressing the finger against the nose, blink gently a few times so that the medicine is evenly distributed on the surface of the eye.
7. Remove excess medication with a clean tissue.
8. Repeat the above steps to administer the medication to the other eye.

If you use more Azelamed than you should
If you use too much Azelamed in your eye, it is unlikely that you will experience any adverse effects. If you are not sure, contact your doctor.

If Azelamed is accidentally swallowed, contact your doctor or nearest emergency department as soon as possible.

There is no experience with the use of toxic (very high, poisonous) doses of azelastine hydrochloride in humans. Based on the results of animal studies, after a significant overdose or in case of poisoning, central nervous system disorders (e.g. anxiety, agitation or deep, long-lasting fatigue or drowsiness) can be expected. In such cases, symptomatic treatment should be applied.

If you forget to take Azelamed
Do not take a double dose to make up for a missed dose. Take the next dose as soon as possible and then take the medicine at the usual time.

If you stop taking Azelamed, your symptoms may return .

If you have any questions on the use of this medicine, ask your doctor or pharmacist.

To treat eye disorders associated with hay fever (seasonal allergic conjunctivitis):
This medicine should not be used in children under 4 years of age because safety and effectiveness have not been established.

To treat eye disorders caused by allergy (nonseasonal [perennial] allergic conjunctivitis):
This medicine should not be used in children under 12 years of age because safety and effectiveness have not been established.

When not to use Azelamed

• If you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine.